A study on the safety and effectiveness of "a weight loss program by setting energy intake considering changes in basal metabolic rate"
- Conditions
- Obesity
- Registration Number
- JPRN-UMIN000044385
- Lead Sponsor
- Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
The exclusion criteria are as follows: 1) Secondary obesity (symptomatic obesity) 2) Patients who had a history of highly invasive surgery, severe trauma, severe infection disease, malignant tumor, or hyperthyroidism within six months 3) Patients with severe impairment in cardiorespiratory, renal or liver function to whom exercise therapy is not applicable (includes patients estimated glomerular filtration rate < 30 mL/min/1.73 m2) 4) Patients with severe musculoskeletal impairment to whom exercise therapy is not applicable 5) Patients who are pregnant, suspected of being pregnant, within 28 days of parturition, or breastfeeding 6) Patients who are judged by their physicians to be unsuitable for participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in body weight
- Secondary Outcome Measures
Name Time Method Changes in resting metabolic rate, body composition, and BMI Changes in HbA1c level, lipids, and blood pressure Changes in various blood and urine test items Changes in calorie intake Changes in physical activity Change in hunger scale 3% or 5% weight loss achievement rate Adverse events (safety) An exploratory study in patients with high weight loss